POLICY AND PROCEDURE 1 26 12/9/15 340B Compliance.pdf · UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective Date: 11/6/13 NUMBER: 30.55 Page 1 of 26 Reviewed: Revised:

UTMB CMC

PHARMACY DEPARTMENTAL

POLICY AND PROCEDURE

Effective Date: 11/6/13

NUMBER: 30.55

Page 1 of 26

Reviewed:

Revised: 12/9/15

340B PROGRAM COMPLIANCE

SUBJECT: 340B Program Compliance

PURPOSE: To ensure that the UTMB CMC Department of Pharmacy is in compliance with 340B program

standards on an ongoing basis.

POLICY: The UTMB CMC Department of Pharmacy complies with all requirements and restrictions of

Section 340B of the Public Health Service Act and any accompanying regulations or guidelines

including, but not limited to, the prohibition against duplicate discounts/rebates under Medicaid,

and the prohibition against transferring drugs purchased under 340B to anyone other than a

patient of UTMB. Policies, procedures, systems, and internal controls are in place to reasonably

ensure ongoing compliance with all 340B requirements.

DEFINITIONS:

340B Eligible Entity - 340B covered entities are facilities/programs listed in the 340B Statute as eligible to

purchase drugs through the 340B Program and appear on the Office of Pharmacy Affairs 340B Database.

340B Eligible Patient - In summary, an individual is a “patient” of a covered entity (with the exception of

State-operated or funded AIDS drug purchasing assistance programs) only if:

1. the covered entity has established a relationship with the individual, such that the covered entity

maintains records of the individual’s health care; and

2. the individual receives health care services from a health care professional who is either employed by

the covered entity or provides health care under contractual or other arrangements (e.g. referral for

consultation) such that responsibility for the care provided remains with the covered entity; and

3. the individual receives a health care service or range of services from the covered entity which is

consistent with the service or range of services for which grant funding or Federally-qualified health

center look-alike status has been provided to the entity. Disproportionate share hospitals are exempt

from this requirement.

An individual will not be considered a “patient” of the entity for purposes of 340B if the only health care

service received by the individual from the covered entity is the dispensing of a drug or drugs for subsequent

self- administration or administration in the home setting.

340B Program - Section 340B of the Public Health Service Act (1992) requires drug manufacturers

participating in the Medicaid Drug Rebate Program to sign an agreement with the Secretary of Health and

Human Services. This agreement limits the price manufacturers may charge certain covered entities for covered

outpatient drugs. The resulting program is called the 340B Program.

Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) – The

government agency that administers the 340B program.

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Group Purchasing Organization (GPO) - A Group Purchasing Organization (GPO) is an organization created

to leverage the purchasing power of entities to obtain discounts from vendors based on the collective buying

power of the GPO members. The Prime Vendor Apexus Portfolio is not considered a GPO.

GPO exclusion - Disproportionate share hospitals participating in the 340B Program under 42 U.S.C.

256b(a)(4)(L) and (M) are subject to 42 U.S.C. 256b(a)(4)(L)(iii), which states that in order to participate in the

340B Program, these entities may not “obtain covered outpatient drugs through a group purchasing organization

or other group purchasing arrangement.” The GPO exclusion applies to hospitals and their off-site outpatient

clinic sites that are registered on the OPA 340B database as participating in the 340B Program and they cannot

purchase any covered outpatient drugs through a GPO or other group purchasing arrangement. A hospital

subject to the GPO prohibition may not purchase covered outpatient drugs through a GPO for any of its

clinics/departments within the four walls of the hospital (same physical address) under any circumstance.

However, certain off-site outpatient facilities of the hospital may use a GPO for covered outpatient drugs if

those off-site outpatient facilities meet all of the following criteria:

Are located at a different physical address than the parent;

Are not registered on the OPA 340B database as participating in the 340B Program;

Purchase drugs through a separate pharmacy wholesaler account than the 340B participating parent; and

The hospital maintains records demonstrating that any covered outpatient drugs purchased through the

GPO at these sites are not utilized or otherwise transferred to the parent hospital or any outpatient

facilities registered on the OPA 340B database.

Outpatient Status – All patients housed at correctional facilities served by UTMB CMC Department of

Pharmacy have an outpatient status and are served by the onsite clinics.

In-house Pharmacy - A pharmacy that is owned by, and a legal part of, the 340B entity. Typically in-house

pharmacies are listed as shipping addresses of the entity.

PROCEDURE:

I. UTMB CMC uses an in-house pharmacy and pharmacy services are performed in accordance with OPA

requirements and guidelines.

A. 340B drugs are only used for patients at UTMB CMC outpatient clinics that appear in the 340B

database. All patients at the clinics are 340B eligible.

B. UTMB maintains the records of the patients’ health care.

C. UTMB directly employees the prescribers or the prescribers are under contractual agreement.

D. Patients receive their health care from UTMB providers and the providers are responsible for

their care.

E. Medicaid claims and reimbursement are not used for UTMB CMC outpatient clinics.

II. UTMB policies, procedures, systems, and internal controls are in place to reasonably ensure ongoing

compliance with all 340B requirements.

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III. Staff Competency

A. Training is conducted on the 340B inventory management program initially upon hire and

competency is also verified by the Pharmacy Supervisor or designee through verbal assessment as

needed.

B. Pharmacy purchasing and accounting staff engaged in monitoring and using the 340B Program and

program compliance complete training upon hire via webinar on the 340B and Prime Vendor

Programs (https://www.340bpvp.com) and attend the 340B University offered by Apexus.

C. Information about the 340B program is received from the OPA, 340B Prime Vendor Program, and/or

any OPA contractor.

IV. Staff Engaged in 340B Program Compliance

A. Director of Pharmacy

1. Accountable agent for 340B compliance

2. Ensure current policy statements and procedures are in place to maintain program

compliance

3. Must maintain knowledge of the policy changes that impact the 340B program which

includes, but not limited to, HRSA/OPA rules

4. Must communicate any change in clinic eligibility or information to the UTMB Office of

Cost Reimbursements and pharmacy staff

B. Assistant Director of Pharmacy, Regulatory Compliance & Systems

1. Assure appropriate safeguards and system integrity

2. Assist with annual 340B integrity audit

3. Responsible for documentation of policy and procedures

C. Finance Manager

1. Performs the annual 340B integrity audit

2. Responsible for semi-annual physical inventory of pharmacy items

3. Responsible for establishment of pricing methodology and procedures

4. Define process and access to data for compliant identification of utilization for eligible

patients

5. Archive the data so as to be available to auditors when audited

6. Responsible for monitoring the ordering processes, receiving process, and data and

pricing of PIPS (pharmacy inventory pricing system)

7. Responsible for establishment and maintenance of wholesaler and reverse distributor

accounts (340B versus non-340B)

8. Responsible for establishment and maintenance of pharmacy system accounts (340B

versus non-340B) such as IMS, HCC, and Datalogic

9. Review 340B reports detailing purchases and dispensing patterns

D. Senior Pharmacist of Purchasing

1. Responsible for overseeing the ordering of all drugs from the specific accounts as

specified by the process employed

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2. Oversees the purchasing control processes

3. Monitors product minimum and maximum levels to effectively balance product

availability and cost efficient inventory control

4. Knowledgeable of products covered by 340B and Prime Vendor Program pricing

E. Stores Clerk II in Charge of PIPS Management

1. Responsible for monitoring the receiving process, and data and pricing of PIPS

(pharmacy inventory pricing system)

2. Responsible for making corrections in PIPS if needed

F. Senior Technologists Rotation 1, 2 and 3

1. Responsible for daily maintenance of dual inventories in their respective areas

2. Responsible for training staff on use and controls of dual inventories

V. 340B Enrollment

A. Initial Enrollment - The UTMB Office of Cost Reimbursements is responsible for evaluating a

new facility to determine if the location is eligible for participation in the 340B Program. The criteria

used include: service area must be fully integrated into the hospital, appear as allowable on the most

recently filed cost report, have outpatient drug use, and have patients that meet the 340B patient

definition. If the facility meets criteria, the UTMB Office of Cost Reimbursements completes the

OPA online registration process. B. Enrollment Recertification - The UTMB Office of Cost Reimbursements is responsible for the

recertification of information listed in the OPA 340B database annually to ensure the covered

entity listing is complete, accurate, and correct.

C. Changes to Enrollment - A quarterly review of information listed in the OPA 340B database is

conducted by the UTMB Office of Cost Reimbursements. Changes to information (e.g., changes

to entity contact information or shipping address) are reported to the OPA through an online

change request.

VI. 340B Inventory Management

A. 340B inventory is shipped to the UTMB CMC Department of Pharmacy and distributed to the

UTMB CMC outpatient clinics.

B. The UTMB CMC Department of Pharmacy maintains physically separate inventories for 340B

and non-340B inventory items. It does not use a replenishment model (accumulator or split-bill

software) to manage its inventory.

C. Pharmacists and technicians only distribute or dispense 340B drugs to 340B facilities where

eligible patients are housed. 340B eligible UTMB CMC outpatient clinics include:

1. UTMB CMC outpatient clinics located on Texas Department of Criminal Justice

facilities (i.e., UTMB Sector)

2. UTMB CMC outpatient clinics located on Texas Juvenile Justice Department facilities

D. Pharmacists and technicians only distribute or dispense non-340B, non-GPO (e.g., WAC) drugs

to non-340B eligible facilities.

1. Non-340B eligible clinics include Texas Tech University Health Sciences Center clinics

located on Texas Department of Criminal Justice facilities (i.e., Texas Tech Sector).

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E. Staff places 340B orders from the primary wholesaler, Morris & Dickson, through daily

inventory reviews and shelf inspections by using the Morris & Dickson Web Portal. The 340B

orders are placed on a separate wholesaler account. The same process is used for the secondary

wholesaler, AmerisourceBergen, in the event of product shortages. F. Staff checks in 340B inventory by examining the wholesaler invoice against the order, and

reports inaccuracies to the wholesaler. Invoice information is downloaded or input into PIPS.

G. 340B inventory is stored in the pharmacy with a security system. Only pharmacy employees

have access through a badge-ID limited entry system (P&P 01-25 Pharmacy Security).

H. 340B inventory segregation (P&P 30-30 Inventory Management and Controls)

1. Physically separate 340B and non-340B inventories are established by purchase orders

through the use of separate accounts, which segregate inventories at the time of purchase.

2. Upon receipt, 340B inventory is placed into its physically separate inventory. 340B

blister pack cards are marked with a P in the man-readable portion of the barcode and

barcode.

3. Upon receipt, all non-340B inventory is designated (i.e., clearly marked) as non-340B

and placed into its physically separate inventory.

a. Case goods are marked with a non-340B master pack label.

b. Blister pack cards are marked with a W in the man-readable portion of the

barcode and barcode.

c. Unit of use items (e.g., ointments and inhalers) are marked with an X using a UV

marker.

4. All products returned to the wholesaler, other vendors or reverse distributor are returned

on the appropriate 340B or non-340B account to reflect the initial designation of that

item.

5. Non-340B medication drug orders (i.e., prescriptions) are processed at different times of

the day (i.e., wave 10) and on separate distribution sorters (i.e., 40-lane sorter) to

maintain segregation.

6. 340B medication drug orders (i.e., prescriptions) are processed at different times of the

day (i.e., waves 8, 12 and 14) to maintain segregation.

7. Distribution sorters perform a correct inventory check of blister pack cards at the time a

medication drug order is scanned to ensure that 340B inventory was used to fill an order

for 340B eligible patient and vice versa.

8. 340B medication drug orders or inventory returned from UTMB CMC Clinics are

credited to the correct clinic account and returned to the correct 340B inventory if they

can be reused. 340B inventory is identified by the unit designator in the patient label

barcode and/or P in the barcode (P&P 25-20 Returned Medications and Reclamation

Processing).

I. Inventory Transfers

1. Transfers between non-340B and 340B inventory are prohibited except in the case of an

emergency medical situation.

2. Only in the case of an emergency medical situation and with Director of Pharmacy approval

will drugs be transferred from a 340B inventory to a non-340B inventory (P&P 30-25

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Pharmacy Procurement of Drug and Non-Drug Products). In the case of an emergency,

the following procedures will be used:

a. From non-340B to 340B

i. Staff records the transaction on the Medication Borrow/Loan Log

ii. Staff reconciles the process by transfer back to the separated non-340B

inventory area through a purchase on the borrowing area’s 340B account

(340B account) of the same NDC and quantity that was borrowed.

b. From 340B to non-340B

i. Staff records the transaction on the Medication Borrow/Loan Log

ii. Staff reconciles the process by transfer back to the separated 340B

inventory area through a purchase on the borrowing area’s non-340B

account (WAC account) of the same NDC and quantity that was

borrowed.

J. Records will be maintained for a period of time that complies with the university’s official

record retention schedule and all applicable federal, state and local requirements.

VII. Monitoring

A. Auditable records will be maintained to demonstrate compliance with the 340B program.

B. Pharmacy staff will complete random weekly audits (P&P 55-25 Automation Sortation Device)

of shipments to ensure accuracy and to monitor 340B inventory compliance.

C. Pharmacy staff will complete monthly audits of the maintenance and segregation of pharmacy

inventory (340B versus non-340B drugs) to ensure inventory controls are being followed.

Monthly audits will include physical observation of the areas where inventory is stored to verify

340B and non-340B inventory is kept separate and marked appropriately (Attachment A).

D. The Pharmacy will conduct semi-annual 340B integrity audits to ensure that the agency’s

internal controls are in compliance with 340B program standards.

1. An audit report with findings will be written and maintained for a period of time that

complies with all applicable federal, state and local requirements. A copy will be sent to

the UTMB Office of Institutional Compliance.

2. If any internal compliance audit indicates that there has been a violation of 340B program

requirements, it will be reported to the UTMB Office of Institutional Compliance.

3. Audit procedures will include:

a. Semi-annual audits

i. Review of a sample of 50 prescriptions (twenty-five 340B and twenty-five

non-340B prescriptions) covering the preceding six-month period

(Attachments C-D).

ii. The review will include whether the relationship between UTMB and the

individual met HRSA’s patient definition standards (i.e., verification of

clinic and patient eligibility).

iii. The audits will be considered compliant if all 50 prescriptions are found to

be compliant.

b. Once a year the semi-annual audit will also include:

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i. Review of relevant policies and procedures and how they are

operationalized

ii. Review of the maintenance and segregation of pharmacy inventory (340B

versus non-340B drugs) and evidence of compliance with the required

GPO exclusion for covered entities by testing a random sample of 340B

inventory transaction records. The review will include 10 medications in

340B inventory and 10 medications in non-340B inventory (Attachments

E-F) to include beginning inventory balance, purchases, sales, and returns

iii. Interviewing key staff members to ensure understanding of program and

requirements (Attachment G).

References:

US Department of Health and Human Services. Health Resources and Services Administration. Office of

Pharmacy Affairs. Statutory Prohibition on Group Purchasing Organization Participation. 340B Drug Pricing

Program Notice. Release No. 2013-1. February 7, 2013.

Sample 340B Policy & Procedure Manual. A Guide for Disproprionate Share Hosptial (DSH) Leaders.

Apexus. Version 06302015.

https://docs.340bpvp.com/documents/public/resourcecenter/DSH_PolicyManual.docx

340B Compliance Self-Assessment: Policy. A Quick Self-Assessment for DSH Leaders. Apexus. Version

05062015.

https://docs.340bpvp.com/documents/public/resourcecenter/DSH_340B_Compliance_SelfAssessment_Policy.p

df

340B Compliance Self-Assessment: Self-Audit Process. A Sample Self-Audit Process for DSHs. Apexus.

Version 05062015.

https://docs.340bpvp.com/documents/public/resourcecenter/DSH_340B_Compliance_SelfAssessment_DataTra

nsactions.pdf

https://docs.340bpvp.com/documents/public/resourcecenter/DSH_PolicyManual.docx

https://docs.340bpvp.com/documents/public/resourcecenter/DSH_340B_Compliance_SelfAssessment_Policy.pdf

https://docs.340bpvp.com/documents/public/resourcecenter/DSH_340B_Compliance_SelfAssessment_Policy.pdf

https://docs.340bpvp.com/documents/public/resourcecenter/DSH_340B_Compliance_SelfAssessment_DataTransactions.pdf

https://docs.340bpvp.com/documents/public/resourcecenter/DSH_340B_Compliance_SelfAssessment_DataTransactions.pdf

Attachment A

Monthly Inventory Audit

Select 2 areas where inventory is stored to verify 340B and non-340B inventory is kept separate and marked

appropriately.

Date: Auditor:

Inventory Location:

Data Assessment Criteria Findings 1. Physical observation of

inventory

The price plan (340B and non-340B) is clearly identified on

drug packages

Compliant

Noncompliant (explain

below)

2. Physical observation of

inventory

340B and non-340B inventories are kept in physically

separate locations Compliant


below)

3. Review of completed

Medication Borrow/Loan Log

Transfers between 340B and non-340B inventories are

documented with the required approvals per policy 30-25.

Compliant


below)

Describe any areas of noncompliance observed:

List opportunities for improvements or suggested changes:

CC: Finance Manager

Assistant Director Pharmacy Services, Regulatory Compliance & Systems

Director, Pharmacy Services

Attachment B

340B Self-Audit Report

Date: Auditor:

Department:

This audit was performed at the request of the UTMB Office of Institutional Compliance.

Data Assessment Criteria Findings 4. Policies and procedures related

to 340B are current Policies contain relevant criteria from sample DSH 340B

Comprehensive Policy and Procedure Manual

Policies reviewed annually

Date:________________

Compliant

Noncompliant (explain)

5. Clinics receiving 340B

medications are registered on

the OPA database

OPA database

340B ID:______________

Last Quarterly Review Sent to UTMB:_______

Recertification Date:__________

Compliant


6. 340B Transaction samples

(attachment B)

Sample Size n=25

Patient received services from UTMB CMC and

healthcare records are maintained in the EMR

UTMB CMC employee or contract employee wrote

prescriptions

Compliant


7. Non-340B Transaction Samples

(attachment C)

Sample Size n=25

Patient received services from non-eligible sites

confirmed by review of healthcare records

Non-eligible provider wrote prescriptions

Compliant


8. 340B Inventory - Starting

inventory balance at beginning

of sample timeframe and end of

sample timeframe (attachment

D)

Sample Size n=10

Able to provide an accounting disposition for all

inventory supplied in the sample.

GPO was not used to purchase covered outpatient

medications for 340B patient/facility

Separate accounts are used and maintained for 340B and

non-340B purchases

Separate accounts for 340B and non-340B inventory are

used and maintained for returns

Expired, damaged or unused 340B medications are

returned to wholesaler, returned to reverse distributor, or

destroyed (i.e., not donated or diverted).

Compliant


9. Non-340B Inventory - Starting

inventory balance at beginning

of sample timeframe and end of

sample timeframe (attachment

D)

Sample Size n=10


inventory supplied in the sample.

GPO was not used to purchase covered outpatient

medications for non-340B patient/facility

Separate accounts are used and maintained for 340B and

non-340B purchases

Separate accounts for 340B and non-340B inventory are

used and maintained for returns

Expired, damaged or unused 340B medications are

returned to wholesaler, returned to reverse distributor, or

destroyed (i.e., not donated or diverted).

Compliant


10. Interview Questions 340B Self-Audit

Opportunities for improvements or suggested changes:

Cc: Finance Manager

Assistant Director Pharmacy Services, Regulatory Compliance & Systems


AVP, Office of Institutional Compliance

Attachment C

Transaction Samples of Individual Prescriptions

Select 25 transactions (prescriptions) for 340B eligible clinics and complete audit of the sample. Attach a

copy to the 340B Self-Audit Report.

Date: Auditor:

340B Eligible Unit

Unit: Sector:

RX ID Number:

RX Date Written: Date Dispensed:

Patient ID Number: Prescriber:

Drug Description:

SCC #:

NDC#:

Data Data Source Compliant

(Yes/No)

Notes

Clinic Eligibility

Confirmed

Unit of assignment on report

Patient Eligibility

Confirmed

Documentation medication was

ordered in the EMR

Prescriber Eligibility

Confirmed

Report provided by CMC HR

Attachment D

Transaction Samples of Individual Prescriptions

Select 25 transactions (prescriptions) for non-340B eligible clinics and complete audit of the sample. Attach

a copy to the 340B Self-Audit Report.

Non-340B Eligible Unit

Unit: Sector:

RX ID Number:

RX Date Written: Date Dispensed:

Patient ID Number: Prescriber:

Drug Description:

SCC #:

NDC#:

Data Data Source Compliant

(Yes/No)

Notes

Clinic Eligibility

Confirmed

Unit of assignment on report

Patient Eligibility

Confirmed

Documentation medication was

ordered in the EMR

Prescriber Eligibility

Confirmed

Report provided by Texas Tech

EMR Sr Director

Attachment E

Transaction Samples of Individual Medications

Select 10 medications from the 340B inventory and complete audit of the sample. Include at least 3 high-cost medications. Use a 6 month

continuous time frame within the prior year to complete the audit. Attach a copy to the 340B Self-Audit Report.

340B Inventory

Date: Audit Date Range: Auditor:

Drug Name: SCC#: NDC#:

Wholesaler(s):

Invoice(s) #:

Audit Findings: Data Source Compliant Notes

WAC account was not used to purchase covered

outpatient medications for 340B inventory.

Yes

No

Separate accounts are used and maintained for 340B

and non-340B purchases (e.g., WAC).

Wholesaler Account #: Yes

No

WAC account was not used to return outpatient

medications from 340B inventory.

Yes

No

Expired, damaged or unused 340B medications from

the pharmacy inventory are returned to wholesaler,

returned to reverse distributor, or destroyed (i.e., not

donated or diverted).

Reverse Distributor Account #:

Source Report Name: Genco

report Order Details Report

Yes

No

Separate accounts are used and maintained for returns

from units.

Source Report Name: Datalogic

report Unit Totals by Population

by Region

Yes

No

Separate usage records are used and maintained for

340B and non-340B sales

Source Report Name:

PHO438-AU

PHO438-U

Yes

No

340B Inventory Confirmed P designator on blister pack

cards

No UV mark on UOU items

Yes

No

Able to provide an accounting disposition for all Yes

inventory supplied in the sample (calculated quantity

for ending inventory = inventory on hand during

audit).

No

Medication Inventory: Data Source Quantity

Beginning inventory

Semi-Annual inventory

Total purchased Invoices or wholesaler system report +

Total dispensed as prescription System reports

PRS PHO438

HCC 3rd party journal

-

Total distributed as stock System reports

HCC

IMS

-

Returns made by pharmacy (e.g.,

manufacturer, Genco, wholesaler)

Genco report Order Details Report -

Items returned to the pharmacy for

reuse (i.e., reclamation)

Datalogic report Unit Totals by Population by Region +

Calculated quantity for ending

inventory = inventory on hand

during audit

=

Inventory on hand

Location:

Location:

Location:

Location:

Attachment F

Transaction Samples of Individual Medications

Select 10 medications from the non-340B inventory and complete audit of the sample. Include at least 3 high-cost medications. Use a 6 month

continuous time frame within the prior year to complete the audit. Attach a copy to the 340B Self-Audit Report.

Non-340B Inventory

Date: Audit Date Range: Auditor:

Drug Name: SCC#: NDC#:

Wholesaler(s):

Invoice(s) #:

Audit Findings: Data Source Compliant Notes

WAC account was not used to purchase covered

outpatient medications for 340B inventory.

Yes

No

Separate accounts are used and maintained for 340B

and non-340B purchases (e.g., WAC).

Wholesaler Account #: Yes

No

WAC account was not used to return outpatient

medications from 340B inventory.

Yes

No

Expired, damaged or unused 340B medications from

the pharmacy inventory are returned to wholesaler,

returned to reverse distributor, or destroyed (i.e., not

donated or diverted).

Reverse Distributor Account #:

Source Report Name: Genco

report Order Details Report

Yes

No

Separate accounts are used and maintained for returns

from units.

Source Report Name: Datalogic

report Unit Totals by Population

by Region

Yes

No

Separate usage records are used and maintained for

340B and non-340B sales

Source Report Name: PHO438-T

Yes

No

340B Inventory Confirmed N designator on blister pack

cards

UV mark on UOU items

Yes

No


inventory supplied in the sample (calculated quantity

Yes

No

for ending inventory = inventory on hand during

audit).

Medication Inventory: Data Source Quantity

Beginning inventory

Semi-Annual inventory

Total purchased Invoices or wholesaler system report +

Total dispensed as prescription System reports

PRS PHO438

HCC 3rd party journal

-

Total distributed as stock System reports

HCC

IMS

-

Returns made by pharmacy (e.g.,

manufacturer, Genco, wholesaler)

Genco report Order Details Report -

Items returned to the pharmacy for

reuse (i.e., reclamation)

Datalogic report Unit Totals by Population by Region +

Calculated quantity for ending

inventory = inventory on hand

during audit

=

Inventory on hand

Location:

Location:

Location:

Location:

Attachment G

Interview Questions 340B Self-Audit

Date: Auditor:

Finance Manager

Question Response

1. How do you identify areas eligible for 340B

medications?

2. Describe 340B internal audit process

3. Describe dual inventory process and controls

4. Describe drug charge and billing process

5. What type of wholesaler accounts do you use

to purchase outpatient drugs? (Provide list of

accounts)

6. What level of confidence do you have in the

entity’s compliance with 340B program?


Question Response

1. How often are 340B policies and procedures

updated?

2. Describe 340B internal audit process

3. How do you define outpatient in your

institution for 340B purposes?

4. Describe dual inventory process and controls.

5. Who has access to update the entity’s health

care professional list for 340B?

6. Explain how you handle referral prescriptions.

7. How do you know independent agreements for

pharmaceuticals do not violate the GPO

prohibition?

8. What level of confidence do you have in the

entity’s compliance with 340B program?

Senior Pharmacist Purchasing

Question Response

1. How many wholesaler accounts do you

purchase from?

2. What is your role in maintaining 340B

compliance?

3. Describe process for transferring items

between 340B and non-340B inventories on an

emergency basis.

4. What is the process for disposition of expired

medications?

Question Response

5. Describe dual inventory process and controls

6. What records do you provide to the return

company to ensure 340B price is credited?

7. What is the internal policy that addresses 340B

program compliance and where can it be

located?

Senior Technician – Rotation 1, 2 and 3

Question Response

1. What is your role in maintaining 340B

compliance?

2. Describe dual inventory process and controls.

3. Describe process for transferring items

between 340B and non-340B inventories on an

emergency basis.

4. What is the process for disposition of expired

medications?

5. What is the internal policy that addresses 340B

program compliance and where can it be

located?

Attachment E

Price Plan Verification

Unit Unit

Code Customer University

Patient

Pricing

Eligibility

Health Care

Staff Pricing

Eligibility

Officer Pricing

Eligibility Compliant

ALLRED JA TDCJ Texas Tech WAC WAC WAC Yes

No

B MOORE BM TDCJ UTMB 340B WAC WAC Yes

No

BARTLETT BL TDCJ UTMB 340B WAC WAC Yes

No

BATEN NJ TDCJ Texas Tech WAC WAC WAC Yes

No

BETO OB TDCJ UTMB 340B WAC WAC Yes

No

Bonita House TDCJ UTMB WAC Not applicable Not applicable Yes

No

BOYD BY TDCJ UTMB 340B WAC WAC Yes

No

BRADSHAW BH TDCJ UTMB 340B WAC WAC Yes

No

BRIDGEPORT BR TDCJ UTMB 340B WAC WAC Yes

No

BRISCOE DB TDCJ UTMB 340B WAC WAC Yes

No

BYRD DU TDCJ UTMB 340B WAC WAC Yes

No

C MOORE CM TDCJ UTMB 340B WAC WAC Yes

No

CLEMENS CN TDCJ UTMB 340B WAC WAC Yes

No

CLEMENTS BC TDCJ Texas Tech WAC WAC WAC Yes

No

CLEVELAND CV TDCJ UTMB 340B WAC WAC Yes

No

COFFIELD CO TDCJ UTMB 340B WAC WAC Yes

No

COLE CL TDCJ UTMB 340B WAC WAC Yes

Unit Unit


Patient

Pricing

Eligibility

Health Care

Staff Pricing

Eligibility

Officer Pricing


No

CONNALLY CY TDCJ UTMB 340B WAC WAC Yes

No

COTULLA N4 TDCJ UTMB 340B WAC WAC Yes

No

CRAIN GV TDCJ UTMB 340B WAC WAC Yes

No

DALHART DH TDCJ Texas Tech WAC WAC WAC Yes

No

DANIEL DL TDCJ Texas Tech WAC WAC WAC Yes

No

DARRINGTON DA TDCJ UTMB 340B WAC WAC Yes

No

DIBOLL DO TDCJ UTMB 340B WAC WAC Yes

No

DOMINGUEZ BX TDCJ UTMB 340B WAC WAC Yes

No

DUNCAN N6 TDCJ UTMB 340B WAC WAC Yes

No

EASTHAM EA TDCJ UTMB 340B WAC WAC Yes

No

ELLIS OE TDCJ UTMB 340B WAC WAC Yes

No

ESTELLE E2 TDCJ UTMB 340B WAC WAC Yes

No

ESTES VS TDCJ UTMB 340B WAC WAC Yes

No

FERGUSON FE TDCJ UTMB 340B WAC WAC Yes

No

FORMBY FB TDCJ Texas Tech WAC WAC WAC Yes

No

FT STOCKTON N5 TDCJ Texas Tech WAC WAC WAC Yes

No

GARZA NH TDCJ UTMB 340B WAC WAC Yes

No

GIST BJ TDCJ UTMB 340B WAC WAC Yes

No

Unit Unit


Patient

Pricing

Eligibility

Health Care

Staff Pricing

Eligibility

Officer Pricing


GLOSSBRENNER SO TDCJ UTMB 340B WAC WAC Yes

No

GOODMAN GG TDCJ UTMB 340B WAC WAC Yes

No

GOREE GR TDCJ UTMB 340B WAC WAC Yes

No

GURNEY ND TDCJ UTMB 340B WAC WAC Yes

No

HALBERT BB TDCJ UTMB 340B WAC WAC Yes

No

HAMILTON JH TDCJ UTMB 340B WAC WAC Yes

No

HAVINS TH TDCJ Texas Tech WAC WAC WAC Yes

No

HENLEY LT TDCJ UTMB 340B WAC WAC Yes

No

HIGHTOWER HI TDCJ UTMB 340B WAC WAC Yes

No

HILLTOP HT TDCJ UTMB 340B WAC WAC Yes

No

HOBBY HB TDCJ UTMB 340B WAC WAC Yes

No

HODGE HD TDCJ UTMB 340B WAC WAC Yes

No

HOLLIDAY NF TDCJ UTMB 340B WAC WAC Yes

No

HOSPITAL GALVESTON HG TDCJ UTMB 340B Not applicable Not applicable1 Yes

No

HUGHES AH TDCJ UTMB 340B WAC WAC Yes

No

HUNTSVILLE HV TDCJ UTMB 340B WAC WAC Yes

No

Huntsville Memorial Hospital HH TDCJ Not

applicable Not applicable WAC

Yes

No

HUTCHINS HJ TDCJ UTMB 340B WAC WAC Yes

No

JESTER I J1 TDCJ UTMB 340B WAC WAC Yes

Unit Unit


Patient

Pricing

Eligibility

Health Care

Staff Pricing

Eligibility

Officer Pricing


No

JESTER III J3 TDCJ UTMB 340B WAC WAC Yes

No

JESTER IV J4 TDCJ UTMB 340B WAC WAC Yes

No

JOHNSTON JT TDCJ UTMB 340B WAC WAC Yes

No

JORDAN JN TDCJ Texas Tech WAC WAC WAC Yes

No

KEGAN HM TDCJ UTMB 340B WAC WAC Yes

No

KYLE KY TDCJ UTMB 340B WAC WAC Yes

No

LEBLANC BA TDCJ UTMB 340B WAC WAC Yes

No

LEWIS GL TDCJ UTMB 340B WAC WAC Yes

No

LINDSEY LN TDCJ UTMB 340B WAC WAC Yes

No

LOCKHART LC TDCJ UTMB 340B WAC WAC Yes

No

LOPEZ RL TDCJ UTMB 340B WAC WAC Yes

No

LUTHER P2 TDCJ UTMB 340B WAC WAC Yes

No

LYNAUGH LH TDCJ Texas Tech WAC WAC WAC Yes

No

LYNCHNER AJ TDCJ UTMB 340B WAC WAC Yes

No

MARLIN N1 TDCJ UTMB 340B WAC WAC Yes

No

MCCONNELL ML TDCJ UTMB 340B WAC WAC Yes

No

MICHAEL MI TDCJ UTMB 340B WAC WAC Yes

No

MIDDLETON NE TDCJ Texas Tech WAC WAC WAC Yes

No

Unit Unit


Patient

Pricing

Eligibility

Health Care

Staff Pricing

Eligibility

Officer Pricing


MONTFORD JM TDCJ Texas Tech WAC WAC WAC Yes

No

MONTFORD RMF HP TDCJ Texas Tech WAC WAC WAC Yes

No

MT.VIEW MV TDCJ UTMB 340B WAC WAC Yes

No

MURRAY LM TDCJ UTMB 340B WAC WAC Yes

No

NEAL KN TDCJ Texas Tech WAC WAC WAC Yes

No

NEY HF TDCJ UTMB 340B WAC WAC Yes

No

PACK P1 TDCJ UTMB 340B WAC WAC Yes

No

PLANE LJ TDCJ UTMB 340B WAC WAC Yes

No

POLUNSKY TL TDCJ UTMB 340B WAC WAC Yes

No

POWLEDGE B2 TDCJ UTMB 340B WAC WAC Yes

No

RAMSEY R1 TDCJ UTMB 340B WAC WAC Yes

No

ROACH RH TDCJ Texas Tech WAC WAC WAC Yes

No

ROACH CAMPS C1 TDCJ Texas Tech WAC WAC WAC Yes

No

ROBERTSON RB TDCJ Texas Tech WAC WAC WAC Yes

No

RUDD RD TDCJ Texas Tech WAC WAC WAC Yes

No

SAN SABA N2 TDCJ UTMB 340B WAC WAC Yes

No

SANCHEZ RZ TDCJ Texas Tech WAC WAC WAC Yes

No

SAYLE SY TDCJ Texas Tech WAC WAC WAC Yes

No

Unit Unit


Patient

Pricing

Eligibility

Health Care

Staff Pricing

Eligibility

Officer Pricing


SCOTT RV TDCJ UTMB 340B WAC WAC Yes

No

SEGOVIA EN TDCJ UTMB 340B WAC WAC Yes

No

SKYVIEW SV TDCJ UTMB 340B WAC WAC Yes

No

SMITH SM TDCJ Texas Tech WAC WAC WAC Yes

No

STEVENSON SB TDCJ UTMB 340B WAC WAC Yes

No

STILES ST TDCJ UTMB 340B WAC WAC Yes

No

STRINGFELLOW R2 TDCJ UTMB 340B WAC WAC Yes

No

TELFORD TO TDCJ UTMB 340B WAC WAC Yes

No

TERRELL R3 TDCJ UTMB 340B WAC WAC Yes

No

TORRES TE TDCJ UTMB 340B WAC WAC Yes

No

TRAVIS TI TDCJ UTMB 340B WAC WAC Yes

No

TULIA N3 TDCJ Texas Tech WAC WAC WAC Yes

No

VANCE J2 TDCJ UTMB 340B WAC WAC Yes

No

WALLACE WL TDCJ Texas Tech WAC WAC WAC Yes

No

WARE DW TDCJ Texas Tech WAC WAC WAC Yes

No

WHEELER WR TDCJ Texas Tech WAC WAC WAC Yes

No

WILDERNESS 3 W3 TDCJ Texas Tech WAC WAC WAC Yes

No

WILLACY WI TDCJ UTMB 340B WAC WAC Yes

No

WOODMAN WM TDCJ UTMB 340B WAC WAC Yes

Unit Unit


Patient

Pricing

Eligibility

Health Care

Staff Pricing

Eligibility

Officer Pricing


No

WYNNE WY TDCJ UTMB 340B WAC WAC Yes

No

YOUNG GC TDCJ UTMB 340B WAC WAC Yes

No

Ayres AY TJJD UTMB 340B WAC WAC Yes

No

Beto BE TJJD UTMB 340B WAC WAC Yes

No

Brownwood Halfway House H2 TJJD UTMB WAC WAC WAC Yes

No

Corsicana CS TJJD UTMB 340B WAC WAC Yes

No

Cottrell CT TJJD UTMB 340B WAC WAC Yes

No

Evins EV TJJD UTMB 340B WAC WAC Yes

No

Gainsville GA TJJD UTMB 340B WAC WAC Yes

No

Giddings GI TJJD UTMB 340B WAC WAC Yes

No

McFadden Ranch MC TJJD UTMB 340B WAC WAC Yes

No

McLennan MN TJJD UTMB 340B WAC WAC Yes

No

Ron Jackson I BS TJJD UTMB 340B WAC WAC Yes

No

Schaeffer SC TJJD UTMB 340B WAC WAC Yes

No

Tamayo VA TJJD UTMB 340B WAC WAC Yes

No

Willoughby WH TJJD UTMB 340B WAC WAC Yes

No

York YO TJJD UTMB 340B WAC WAC Yes

No

Galveston Teen Center UTMB WAC Not applicable Not applicable Yes

No

Unit Unit


Patient

Pricing

Eligibility

Health Care

Staff Pricing

Eligibility

Officer Pricing


Bridgeport PPT T1 MTC UTMB WAC WAC Not applicable Yes

No

East Texas Treatment XQ MTC UTMB WAC WAC Not applicable Yes

No

South Texas ISF XM MTC UTMB WAC WAC Not applicable Yes

No

West Texas ISF XN

MTC UTMB WAC WAC Not applicable Yes

No

El Paso Co. Jail Annex A1 Burnet

Co. Jail UTMB WAC WAC Not applicable Yes

No

El Paso Co. Detention Facility A2 El Paso

Co. Jail UTMB WAC WAC Not applicable Yes

No

1 HG officers go to Young for vaccines and Postexposure prophylaxis

Documents

POLICY AND PROCEDURE 1 26 12/9/15 340B Compliance.pdf · UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective Date: 11/6/13 NUMBER: 30.55 Page 1 of 26 Reviewed: Revised: